Electronic lab notebook
Encyclopedia
An electronic lab notebook (also known as electronic laboratory notebook, or ELN) is a software program designed to replace paper laboratory notebook
s. Lab notebooks in general are used by scientist
s and technician
s to document research
, experiments and procedures performed in a laboratory. A lab notebook is often maintained to be a legal document and may be used in a court of law as evidence
. Similar to an inventor's notebook
, the lab notebook is also often referred to in patent
prosecution and intellectual property
litigation.
Electronic lab notebooks are a fairly new technology and offer many benefits to the user as well as organizations. For example electronic lab notebooks are easier to search upon, support collaboration amongst many users, and can be made more secure than their paper counterparts.
A good electronic laboratory notebook should be an "out of the box" solution that as standard has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures, spectra, chromatograms, pictures, text, etc where a preconfigured form is less appropriate. All data within the system should be stored in a database (eg. MySQL, MS-SQL, Oracle) and therefore be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms and/or ELN that best meets the requirements of the user.
The application should enable secure forms to be generated that accept laboratory data input via PCs and/or laptops / palmtops, and should be directly linked to electronic devices such as laboratory balances, pH meters, etc. Networked or wireless communications should be accommodated for by the package which will allow data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. A system should also include a scheduling option for routine procedures such as equipment qualification and study related timelines. It should include configurable qualification requirements to automatically verify that instruments have been cleaned and calibrated within a specified time period, that reagents have been QC'd and are not expired, and that workers are trained and authorized to use the equipment and perform the procedures.
Electronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with FDA regulations related to software validation. The purpose of the regulations is to ensure the integrity of the entries in terms of time, authorship, and content. Unlike ELNs for patent protection, FDA is not concerned with patent interference proceedings, but is concerned with avoidance of falsification. Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) and Title 21 CFR Part 11
. Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes. Evidence to show that this is the case is often provided by a Software Requirements Specification (SRS) setting forth the intended uses and the needs that the ELN will meet; one or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification and that the requirements are satisfied under worst-case conditions. Security, audit trails, prevention of unauthorized changes without substantial collusion of otherwise independent personnel (i.e., those having no interest in the content of the ELN such as independent quality unit personnel) and similar tests are fundamental. Finally, one or more reports demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of the ELN software for use. If the reports show that the software failed to satisfy any of the SRS requirements, then corrective and preventive action ("CAPA") must be undertaken and documented. Such CAPA may extend to minor software revisions, or changes in architecture or major revisions. CAPA activities need to be documented as well.
Aside from the requirements to follow such steps for regulated industry, such an approach is generally a good practice in terms of development and release of any software to assure its quality and fitness for use. There are standards related to software development and testing that can be applied (see ref.).
Lab notebook
A lab notebook is a primary record of research. Researchers use a lab notebook to document their hypotheses, experiments and initial analysis or interpretation of these experiments...
s. Lab notebooks in general are used by scientist
Scientist
A scientist in a broad sense is one engaging in a systematic activity to acquire knowledge. In a more restricted sense, a scientist is an individual who uses the scientific method. The person may be an expert in one or more areas of science. This article focuses on the more restricted use of the word...
s and technician
Technician
A technician is a worker in a field of technology who is proficient in the relevant skills and techniques, with a relatively practical understanding of the theoretical principles. Experienced technicians in a specific tool domain typically have intermediate understanding of theory and expert...
s to document research
Research
Research can be defined as the scientific search for knowledge, or as any systematic investigation, to establish novel facts, solve new or existing problems, prove new ideas, or develop new theories, usually using a scientific method...
, experiments and procedures performed in a laboratory. A lab notebook is often maintained to be a legal document and may be used in a court of law as evidence
Evidence (law)
The law of evidence encompasses the rules and legal principles that govern the proof of facts in a legal proceeding. These rules determine what evidence can be considered by the trier of fact in reaching its decision and, sometimes, the weight that may be given to that evidence...
. Similar to an inventor's notebook
Inventor's notebook
An inventor's notebook is used by inventors, scientists and engineers to record their ideas, invention process, experimental tests and results and observations. It is not a legal document but is valuable, if properly organized and maintained, since it can help establish dates of conception and...
, the lab notebook is also often referred to in patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
prosecution and intellectual property
Intellectual property
Intellectual property is a term referring to a number of distinct types of creations of the mind for which a set of exclusive rights are recognized—and the corresponding fields of law...
litigation.
Electronic lab notebooks are a fairly new technology and offer many benefits to the user as well as organizations. For example electronic lab notebooks are easier to search upon, support collaboration amongst many users, and can be made more secure than their paper counterparts.
Types
ELNs can be divided into two categories:- "Specific ELNs" contain features designed to work with specific applications, scientific instrumentation or data types.
- "Cross-disciplinary ELNs" or "Generic ELNs" are designed to support access to all data and information that needs to be recorded in a lab notebook.
Objectives
A good electronic laboratory notebook should offer both a secure environment to protect the integrity of both data and process, whilst also affording the flexibility to adopt new processes or changes to existing processes without recourse to further software development. The package architecture should be a modular design, so as to offer the benefit of minimizing validation costs of any subsequent changes that you may wish to make in the future as your needs change.A good electronic laboratory notebook should be an "out of the box" solution that as standard has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures, spectra, chromatograms, pictures, text, etc where a preconfigured form is less appropriate. All data within the system should be stored in a database (eg. MySQL, MS-SQL, Oracle) and therefore be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms and/or ELN that best meets the requirements of the user.
The application should enable secure forms to be generated that accept laboratory data input via PCs and/or laptops / palmtops, and should be directly linked to electronic devices such as laboratory balances, pH meters, etc. Networked or wireless communications should be accommodated for by the package which will allow data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. A system should also include a scheduling option for routine procedures such as equipment qualification and study related timelines. It should include configurable qualification requirements to automatically verify that instruments have been cleaned and calibrated within a specified time period, that reagents have been QC'd and are not expired, and that workers are trained and authorized to use the equipment and perform the procedures.
Regulatory and legal aspects
The laboratory accreditation criteria found in the ISO 17025 standard needs to be considered for the protection and computer backup of electronic records. These criteria can be found specifically in clause 4.13.1.4 of the standard.Electronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with FDA regulations related to software validation. The purpose of the regulations is to ensure the integrity of the entries in terms of time, authorship, and content. Unlike ELNs for patent protection, FDA is not concerned with patent interference proceedings, but is concerned with avoidance of falsification. Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) and Title 21 CFR Part 11
Title 21 CFR Part 11
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration guidelines on electronic records and electronic signatures in the United States...
. Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes. Evidence to show that this is the case is often provided by a Software Requirements Specification (SRS) setting forth the intended uses and the needs that the ELN will meet; one or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification and that the requirements are satisfied under worst-case conditions. Security, audit trails, prevention of unauthorized changes without substantial collusion of otherwise independent personnel (i.e., those having no interest in the content of the ELN such as independent quality unit personnel) and similar tests are fundamental. Finally, one or more reports demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of the ELN software for use. If the reports show that the software failed to satisfy any of the SRS requirements, then corrective and preventive action ("CAPA") must be undertaken and documented. Such CAPA may extend to minor software revisions, or changes in architecture or major revisions. CAPA activities need to be documented as well.
Aside from the requirements to follow such steps for regulated industry, such an approach is generally a good practice in terms of development and release of any software to assure its quality and fitness for use. There are standards related to software development and testing that can be applied (see ref.).
ELN vendors
- LabArchives "Chance Favors the Organized Lab"
- shareSignELN - based on Microsoft SharePoint 2010 and Word 2010
- iPad ELN
- Sapio SciencesSapio SciencesSapio Sciences is a software vendor that develops and markets the Exemplar product line. Exemplar is a versatile software tool that encompasses Laboratory Information Management, Electronic Laboratory Notebook, Cheminformatics and Data Management in a single framework.- Corporate History :Sapio...
- GenohmGenohmGenohm is a well established bioinformatics company with offices in Belgium and Switzerland . Genohm has around 20 employees divided over its two offices.Genohm started in 2002 as Biorebel, with technology developed at the University of Ghent...
- e-Notebook from CambridgeSoftCambridgeSoftCambridgeSoft was a cheminformatics software company based in Cambridge, Massachusetts, USA. The company was founded in 1986 by Stewart Rubenstein, then a graduate student in chemistry at Harvard University, and ended operations as an independent company in 2011. The historical main product is the...
- Symyx ELN
- Agilent OpenLAB ELN
- IDBS E-WorkBook Suite
- Rescentris CERF ELN
- Ruro Sciency ELN
- Core Informatics
Open source alternatives
- EMSL Collaboratory ELN - Originally developed at the Pacific Northwest National Laboratory
- MyLabBook - An installation profile project for the Drupal content management system
- open enventory - specialized on molecular chemistry
See also
- Lab notebookLab notebookA lab notebook is a primary record of research. Researchers use a lab notebook to document their hypotheses, experiments and initial analysis or interpretation of these experiments...
- Inventor's notebookInventor's notebookAn inventor's notebook is used by inventors, scientists and engineers to record their ideas, invention process, experimental tests and results and observations. It is not a legal document but is valuable, if properly organized and maintained, since it can help establish dates of conception and...
- Invention disclosureInvention disclosureAn invention disclosure, or invention disclosure report, is a confidential document written by a scientist or engineer for use by a company's patent department, or by an external patent attorney, to determine whether patent protection should be sought for the described invention. It may follow a...
- Laboratory informaticsLaboratory informaticsLaboratory Informatics is the specialized application of information technology aimed at optimizing laboratory operations. It encompasses electronic lab notebooks, sample management, data acquisition, data processing, reporting and scientific data management...